Table 1.
Outcome | Method | A1 Baseline |
A2, 3, 4 1, 3, 6 months |
A5 12 months |
A6 18 months |
A7 24 months |
A8 36 months |
Primary outcome | |||||||
Lymphoedema-specific QoL | Lymphoedema Functiong, Disability and Health (Lymph-ICF) questionnaire for upper or lower limb lymphoedema13 19 20 27 | X | X | ||||
Secondary outcomes | |||||||
Self-reported questionnaire | |||||||
Lymphoedema-specific QoL | See primary outcome | X | X | X | X | X | |
Duration (key secondary outcome) and experience of wearing compression garment | Compression questionnaire developed by the International Compression Club (or ICC compression questionnaire)28 | X | X | X | X | X | X |
Health-related QoL | EuroQol-5D-5L which is a health status measure developed by the EuroQol group containing 5 dimensions and 5 levels29 | X | X | X | X | X | X |
Work capacity and ability | Work Productivity and Activity Impairment questionnaire30; QuickScan 1831 | X | X | X | X | X | X |
Physical activity level | International Physical Activity Questionnaire32 | X | X | X | X | X | X |
Costs related to lymphoedema and its treatment* | Study-specific questionnaire | X | X | X | X | X | |
Usual care and self-management*†, including need for intensive treatment | Study-specific questionnaire | X | X | X | X | X | |
Assessments | |||||||
Limb volume (key secondary outcome) | Circumference measurements every 4 cm with perimeter16 33–35 | X | X | X | X | X | X |
Hand/foot volume | Water displacement method of hand or foot34 36 | X | X | X | X | X | X |
Failure to reduce hours a day of wearing compression garment | Based on change in limb volume | X | X | X | X | ||
Body weight | Scale | X | X | X | X | X | X |
Infection previous 18 months | Interview | X | X | X | |||
Recurrence of cancer | Interview and medical file | X | X | ||||
Adverse events and complications of surgery | Interview and medical file | X | X | X | X | X | |
Lymphatic transport | Lymphofluoroscopy using Indocyanine Green (or ICG fluoroscopy)37; lymphoscintigraphy38 39 | X | X |
*Information is collected on a monthly basis.
†No secondary outcome.
QoL, quality of life.